Resorbable Barrier for the Prevention of Abdominal and Peri-hepatic Adhesion Formation (SEPRAC2T)

Léon Bérard Center

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Procedure: - use of resorbable membrane Seprafilm

Procedure: without resorbable barrier (seprafilm)

Study type

Interventional

Funder types

Other

Identifiers

NCT01262417

SEPRAC2T

Details and patient eligibility

About

The purpose of this study is to evaluate the efficiency of a resorbable barrier membrane for the prevention of abdominal and peri-hepatic adhesion in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases.

Eligible patients will be randomly assigned to one of 2 arms:

Seprafilm group (receiving resorbable barrier membrane during the first surgery)
No-treatment control group (without seprafilm barrier during the first surgery)

The primary objective is to establish, in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases, the efficiency of a resorbable barrier membrane (Seprafilm) for limiting abdominal and peri-hepatic adhesion during the second operation.

This study is a prospective multicentric phase II, controlled, randomized and non comparative trial.

A total of 60 patients will be enrolled: 45 will receive Seprafilm whereas 15 will be assigned to the no-treatment control group. The inclusion period should be approximately 18 months. The follow up period after the second surgery will be 3 years.

Full description

The secondary objectives of the study are:

During and after the 1st surgical procedure To evaluate immediate complications (during surgery), early complications (during post-surgery hospitalization) and late complications (between 1st and 2nd surgeries) in relation with operating procedure and use of resorbable membrane.

During and after the 2nd surgical procedure

To evaluate abdominal and peri-hepatic adhesion (at the site of the 1st surgery), with qualitative and quantitative description.
To evaluate intestinal adhesion (in the small intestine), with quantitative description.
To evaluate immediate complications (during surgery), early complications (during post-surgery hospitalization) and late complications (in the month following the intervention) in relation with operating procedure.
To evaluate post-operative rehabilitation
To assess tumour evolution in patients over a period of 3 years after the 2nd surgery.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Women and men aged ≥ 18 years
Colorectal cancer with synchronous or metachronous hepatic metastases
Patients requiring two-stage surgery with laparotomy for the resection of hepatic metastases
The 2 operations should be scheduled in the same centre
The 2 operations should be scheduled at an interval of 1 to 6 months
Patient affiliated with social security
Patient able to read and write French
Written, voluntary, informed consent

Exclusion criteria

Patient with previous hepatic or biliary surgery through supra-umbilical incision (except biliary surgery with laparotomy more than 6 months previously)
Patient with previous major surgery except colorectal surgery for resection of primitive tumour
Metastasis removable in one surgical procedure
Non resectable metastasis
Follow-up impossible for social, geographical, familial or psychological reasons
Patient deprived of freedom
Patient enrolled in another experimental surgery trial
Pregnant or lactating woman